3D Ultrasound for Breast Disease

Overseen By Anat Kornecki, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Breast implants, ABUS contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment 3D Ultrasound Image Acquisition for breast disease?

Research shows that 3D ultrasound can provide better image quality and diagnostic accuracy compared to traditional 2D ultrasound for evaluating breast lesions and solid breast masses, which may help in more accurately identifying and assessing breast diseases. ^{1 2 3 4 5}

Is 3D ultrasound generally safe for humans?

Research on ultrasound contrast agents, used to enhance ultrasound images, shows they are generally safe with very low rates of serious adverse events. For example, a large study of SonoVue in abdominal exams found only 0.0086% serious adverse events, indicating a good safety profile. ^{6 7 8 9 10}

How does 3D ultrasound differ from other treatments for breast disease?

3D ultrasound for breast disease is unique because it provides a more comprehensive and reliable imaging technique compared to traditional 2D ultrasound. It automatically scans almost the entire breast, reducing the subjective nature of the examination, and allows for better follow-up and monitoring. This method is also cost-effective, portable, and suitable for point-of-care screening, especially beneficial for patients with dense breast tissue where traditional mammography may be less effective. ^{1 11 12 13 14}

What is the purpose of this trial?

This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.

Eligibility Criteria

This trial is for adult females at least 18 years old, scheduled for mammography and ultrasound assessment for breast disease. Participants must be proficient in English to understand the procedure and give informed consent.

Inclusion Criteria

I am scheduled for an ABUS breast screening.

I am scheduled for a short-term Automated Breast Ultrasound.

You possess a proficient level of English literacy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo routine 2D ultrasound and additional 3D ultrasound imaging using a custom device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

24 months

Treatment Details

Interventions

• 3D Ultrasound Image Acquisition

Trial Overview The study tests a custom device developed by Dr. Aaron Fenster's lab that acquires 3D ultrasound images using a commercial machine, comparing its effectiveness with GE Medical's InveniaTM clinical system.

Participant Groups

Group I: Patients at Risk of Breast Cancer Experimental Treatment 1 Intervention

These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Findings from Research

Three-dimensional (3D) ultrasound provides different characteristics for breast lesions compared to conventional two-dimensional (2D) ultrasound, particularly highlighting the retraction phenomenon as a significant factor in lesion characterization.

Despite the differences in ultrasound features, the diagnostic accuracy of 3D and 2D ultrasound is nearly identical, suggesting that 3D ultrasound could be a valuable adjunct to 2D ultrasound in breast imaging, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasound for the assessment of breast lesions. Watermann, DO., Földi, M., Hanjalic-Beck, A., et al.[2019]

The study analyzed 221 breast tumors using 3D ultrasonography and found that the convergence sign is significantly associated with various prognostic factors, including smaller tumor size and positive hormone receptor status, indicating its potential as a predictive marker for breast cancer prognosis.

Irregular tumor margins observed in 3D ultrasonography were linked to axillary lymph node metastases and negative C-erb-B2 expression, suggesting that these imaging characteristics can help inform treatment decisions for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasonography for the prediction of breast cancer prognosis. Xu, G., Han, T., Yao, MH., et al.[2016]

3D ultrasonography provided superior image quality compared to 2D ultrasonography when evaluating 507 solid breast masses, particularly for larger masses over 10 mm.

Despite the improved image quality with 3D imaging, there was no significant difference in diagnostic accuracy for breast cancer detection when compared to 2D imaging, indicating that both methods are equally effective in diagnosing breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of 2D and 3D ultrasonography for evaluation of solid breast masses. Cho, KR., Seo, BK., Lee, JY., et al.[2016]

The survey highlights current opinions on the safety of diagnostic ultrasound applications, indicating a need for ongoing evaluation of its safety profile.

The paper outlines specific labeling requirements for ultrasound equipment as proposed by the Netherlands' Committee on the Safety of Ultrasound, emphasizing the importance of clear communication regarding output levels and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. Thijssen, JM., van Beekum, WT., Daniëls, O., et al.[2005]

In a review of over 201,000 administrations of ultrasound enhancement agents (UEAs), severe and critical adverse drug reactions (ADRs) were found to be more frequent with Lumason compared to Definity, with rates of 0.0848% for severe and 0.0330% for critical ADRs associated with Lumason.

The frequency of severe ADRs with Lumason has increased in recent years, and patients experiencing these reactions were more likely to have received a COVID-19 vaccination, particularly the Moderna vaccine, suggesting a potential link that requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice. Ali, MT., Johnson, M., Irwin, T., et al.[2023]

In a study involving 34 pediatric patients with solid tumors, the intravenous administration of ultrasound contrast agents was found to be safe, with no significant changes in hemodynamic status observed during or after the procedure.

Only 2.2% of the procedures resulted in mild, transient side effects, such as taste alteration and tinnitus, which did not recur in subsequent examinations, indicating a favorable safety profile for these agents in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in the pediatric oncologic population: a single-institution experience. Coleman, JL., Navid, F., Furman, WL., et al.[2021]

In a study involving 23,188 abdominal examinations using the ultrasound contrast agent SonoVue, only 29 adverse events (AEs) were reported, indicating a very low incidence of complications.

The overall rate of serious adverse events was extremely low at 0.0086%, and SonoVue demonstrated a good safety profile, comparable to or better than other contrast agents used in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Piscaglia, F., Bolondi, L.[2022]

In a large retrospective analysis involving over 78,000 doses of ultrasound contrast agents (Definity and Optison), only 0.01% of patients experienced severe adverse reactions, indicating a strong safety profile for these agents.

The study found that severe reactions were primarily in outpatients, with no serious events reported in critically ill patients, suggesting that ultrasound contrast agents are safe for use in a variety of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. Wei, K., Mulvagh, SL., Carson, L., et al.[2022]

Three-dimensional (3-D) ultrasound provides a comprehensive and automated scanning of the breast, which enhances the reliability of reviews and follow-ups compared to traditional ultrasound methods.

This technique has the potential to be integrated into routine radiological practices and could be beneficial for population screening programs for breast cancer, improving early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[3-D ultrasound of the breast: less dependent on the investigator]. de Jong, MD., Dubelaar, IJ., Fassaert, TA., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasound for the assessment of breast lesions. [2019]

2. Cyprus pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasonography for the prediction of breast cancer prognosis. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

A comparative study of 2D and 3D ultrasonography for evaluation of solid breast masses. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

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5. England pubmed.ncbi.nlm.nih.gov

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6. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. [2005]

7. United States pubmed.ncbi.nlm.nih.gov

Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in the pediatric oncologic population: a single-institution experience. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Virtual navigator 3D panoramic for breast examination. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Automated quantitative volumetric breast ultrasound data-acquisition system. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

[3-D ultrasound of the breast: less dependent on the investigator]. [2016]

14. England pubmed.ncbi.nlm.nih.gov

Cost-effective, portable, patient-dedicated three-dimensional automated breast ultrasound for point-of-care breast cancer screening. [2023]